An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment

NCT06675955 · tracked via the Priya Life Science Germany tracker

Sponsor

Hoffmann-La Roche

Phase

Phase 3

Started

2024-12-13

Last updated

2026-02-18

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Ocrelizumab →

Ocrelizumab: Ocrelizumab will be administered at the approved dose of 600 mg, IV infusion or 920 mg, SC injection, according to the regimen in the parent study.

Study summary

The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.

From Protocol Version 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\] at the time of roll-over and who do not have access to the ocrelizumab treatment locally * The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study * Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in participants of childbearing potential Exclusion Criteria: * Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant * Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant * Permanent premature discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable) * Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications * Concurrent participation in any therapeutic clinical trial (other than the parent study) * Immunocompromised state * Known active malignancy or are being actively monitored for recurrence of malignancy * Known presence of other neurological disorders

Primary outcome measure(s)

Change From Baseline to End of Study in the Physical Functioning Score of the Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders - Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a) — Baseline up to 5 years
PROMISnq PFMS-15a includes 15 items that evaluate the impact of MS on a participant's physical functioning, including mobility, upper limb function and activities of daily living. Nine items assess the degree of difficulty in completing physical activities using a 5-point verbal rating scale ranging from 5="without any difficulty" to 1="unable to do". Four items assess physical function limitations, rated from 5="not at all" to 1="cannot do". Two items assess the amount of difficulty associated with selected physical activities, rated from 5="no difficulty" to 1="can't do". Scores are reported as a standardized T-score metric, with higher scores reflecting better physical functioning.
Number of Eligible Participants who Have Received Access to Ocrelizumab in the Study — Up to 5 years

Trial sites (44)

Facility	City	Region	Status
CHU Amiens Hopital Sud	Amiens Cedex1	France	Recruiting
CHU de Besancon Hopital Jean Minjoz	Besançon	France	Recruiting
Groupe Hospitalier Pellegrin	Bordeaux	France	Recruiting
CHU Brest Hopital La Cavale Blanche	Brest	France	Recruiting
Hopital neurologique Pierre Wertheimer - CHU Lyon	Bron	France	Recruiting
CHU De Caen	Caen	France	Recruiting
Hopital Gabriel Montpied CHU de Clermont-Ferrand	Clermont-Ferrand	France	Withdrawn
CH St Vincent de Paul	Lille	France	Recruiting
Hopital Gui de Chauliac	Montpellier	France	Recruiting
Hopital Nord Laennec	Nantes	France	Recruiting
Hôpital Pasteur	Nice	France	Recruiting
GroupeHospitalo-Universitaire Caremeau	Nîmes	France	Recruiting
Hopital de Hautepierre	Strasbourg	France	Recruiting
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH	Ulm	Germany	Recruiting
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz	Westerstede	Germany	Recruiting
Deutsche Klinik für Diagnostik	Wiesbaden	Germany	Recruiting
Krasnoyarsk State Medical Academy	Krasnoyarsk	Krasnoyarsk Krai	Recruiting
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency	Krasnoyarsk	Krasnoyarsk Krai	Recruiting
City Clinical Hospital #24	Moscow	Moscow Oblast	Recruiting
Federal center of brain research and neurotechnologies	Moskva	Moscow Oblast	Recruiting
National Center of Social Significant Disease	Saint Petersburg	Sankt-Peterburg	Recruiting
LLC Osnova	Saint Petersburg	Sankt-Peterburg	Recruiting
N.P. Bechtereva Institute of the Human Brain	Saint Petersburg	Sankt-Peterburg	Recruiting
City Hospital #40 of Kurortniy Administrative District	Saint Petersburg	Sankt-Peterburg	Recruiting
SHI Sverdlovsk Regional Clinical Hospital #1	Yekaterinburg	Sverdlovsk Oblast	Recruiting
Vertebronevrologiya LLC	Kazan'	Tatarstan Republic	Recruiting
Ulyanovsk Regional Clinical Hospital	Ulyanovsk	Ulyanovsk Oblast	Recruiting
Center of Cardiology and Neurology	Kirov	Russia	Recruiting
Regional clinical hospital named after prof. S.V. Ochapovsky	Krasnodar	Russia	Recruiting
FSBIH Siberian Regional Medical Centre of FMBA of Russia	Novosibirsk	Russia	Recruiting
Perm SMA n.a. academ. E.A. Vagner	Perm	Russia	Recruiting
5th Cherkasy City Center of Primary Health Care	Cherkasy	Ukraine	Recruiting
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?	Chernihiv	Ukraine	Recruiting
Bukovinsky SMU RMI Chernivtsi RCH	Chernivtsi	Ukraine	Recruiting
SI USSRI of Medical and Social Problems of Disabilities of MOHU	Dnipro	Ukraine	Recruiting
Regional Clinical Hospital	Ivano-Frankivsk	Ukraine	Recruiting
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU	Kharkiv	Ukraine	Recruiting
Medical Center Dopomoga Plus	Kyiv	Ukraine	Recruiting
Medical Center of Private Execution First Private Clinic	Kyiv	Ukraine	Recruiting
Volyn Regional Clinical Hospital	Lutsk	Ukraine	Recruiting

+ 4 more sites — see the full list on the official registry below.

On this site

📄 Ocrevus (ocrelizumab) drug profile →

More Hoffmann-La Roche trials in Germany

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting

A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration Active, not recruiting

A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer Recruiting

Study Of Entrectinib (Rxdx-101) in Children and Adolescents With Locally Advanced Or Metastatic Solid Or Primary CNS Tumors And/Or Who Have No Satisfactory Treatment Options Active, not recruiting

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting

Other trials for the same condition

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS) Active, not recruiting

Study to Evaluate the Efficacy, Safety, and Tolerability of IMU-838 in Patients With Relapsing Multiple Sclerosis Active, not recruiting

Strategies for Adaptive Follow-up and Evaluation - Guiding Use of Indicators for De-Escalation in Multiple Sclerosis Recruiting

A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis Active, not recruiting

Clinical Impact Through AI-assisted MS Care - A Prospective Multi-center Study Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06675955 on ClinicalTrials.gov ↗ ← All trials in Germany